I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asia. I've received numerous awards including an Honorary Doctor of Science degree from the University of New Hampshire. I am also the author of "Drug Truths: Dispelling The Myths Of R&D" and the recently published Devalued And Detrusted: Can The Pharmaceutical Industry Restore Its Broken Image?" I am also a senior partner at PureTech Ventures.

Thus, the results of a recently published article from PatientView Quarterly entitled “The Corporate Reputation of Pharma – The Patient Perspective” cannot be a surprise. PatientView surveyed 600 international, national and regional patient groups, asking them for their opinions on the corporate reputation of pharma in general and 29 leading pharma companies in particular. While international in scope (the study was largely European with 72% of the responses coming from European organizations and 19% from North America), nevertheless, the results strike a universal chord.

What is driving this negative view of pharma from a patient’s perspective? The patient groups listed a number of areas where pharma was rated as having a “poor” record including:

1) a lack of fair pricing policies leading to unseemly profits (50%);

2) a lack of transparency in all corporate activities (48%);

3) management of adverse event news (37%);

4) acting with integrity (32%).

There were a number of themes that supported these poor ratings: lack of affordable medicines, a perception that the industry is preoccupied with drugs that offer only short-term health benefits, inappropriate marketing of drugs and lack of transparency in reporting results from negative clinical trials.

In fairness to pharma, it has been trying to improve in these areas. But it is time for the industry to redouble its efforts. As I have outlined in Devalued & Distrusted – Can the pharma industry restore its broken image?, here are some thoughts.

1) Transparency of payments to healthcare professionals – Physicians are invaluable to companies in terms of offering advice on clinical trials, leading these trials, publishing and discussing the results, etc. Doctors are justifiably paid for these services. But patients have a right to know just how much doctors are being paid. Interestingly, Pfizer has been publishing ALL physician payments since 2010. There is no reason why all companies can’t be doing this. Such action would make the current issues on enactment of the “Sunshine Act” moot.

2) Transparency of clinical trial data – The industry is often accused of hiding negative data. The industry now posts all clinical trials it is conducting on a government website, ClinicalTrials.gov. The problem is that it has been slow to enter the final results from these studies in a timely matter. The industry needs to conform to the expectation that all results be entered within 30 months of the last patient completing the study. To show how transparent a company CAN be on data disclosure, GSK last October announced a policy that it would allow access to outside scientists to probe all the data it holds on clinical trials. Other companies need to emulate this policy.

3) Stop the illegal detailing of drugs – There is nothing more depressing for an advocate of the pharmaceutical industry to read about than yet another multi-billion dollar fine being levied against a drug manufacturer for trying to sell a drug for which it is not approved. I realize that companies have taken internal steps to prevent this, but the practice must stop if companies are going to restore faith that they exist to benefit patients and not only for profits.

4) Drop the TV Ads – I realize that companies are allowed to advertise their drugs in accordance to FDA guidelines. But the ads may be doing more harm than good. The litany of side-effects that must be discussed is numbing and probably doesn’t provide a sense of the true risk-benefit for that medication. Plus, the public views these ads to be a waste of funds that could otherwise be invested in R&D or in lessening drug costs.

The pharmaceutical industry plays a valued and unique role in healthcare. The discovery and development of new drugs is largely driven by it. Any major treatment or cure for Alzheimer’s disease will likely come from these companies. Unfortunately, the importance of this industry is lost on the vast majority of patients due to the attacks on the industry’s credibility. It is time to take the necessary steps to change this negative perception.

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It would also help if the industry would stop casting aside some of its best vocal advocates, i.e., those who understand and can explain in plain language what the industry does and why it has social benefits – when done according to the laws of the land that create a level playing field.

John LaMattina has been forced to change his position on trials transparency, but continues to get his facts wrong.

Three months ago he claimed that the problem of drug companies withholding trial data had been fixed by the requirement to post results on clinicaltrials.gov. As I explained at the time, LaMattina’s claim was false:

I am pleased to see Mr LaMattina recognises it is untenable for him to deny this ongoing problem, and now admits that these laws have been widely ignored. He does not however discuss the extent to which this law is currently being flouted: the best currently available evidence, published in the British Medical Journal in 2012, shows that less than half of all trials have met the compulsory reporting requirement at clinicaltrials.gov

Unfortunately Mr LaMattina also continues to display his ignorance of what this law requires. He says that companies should post results within 30 months. In fact the FDA Amendment Act 2007 requires that results must be posted to clinicaltrials.gov within one year.

http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

It would be helpful if John LaMattina could clarify whether he is advising companies to ignore the law, and illegally withhold the results of clinical trials from doctors and patients (as Pfizer did – legally – when LaMattina was head of R&D at the company, for example in the case of reboxetine); or if he is once again simply wrong on the facts.

We must all welcome representatives of the pharmaceutical industry who campaign for greater integrity, but it is important that they do not mislead, dismiss legitimate concerns, or gloss over ongoing problems, as LaMattina has done here and elsewhere.

First, I’d like to point out that Dr. Goldacre has criticized me for not reading his book. Actually, I ordered his book on Amazon last December. It will not be shipped until next month. I look forward to reading it, particularly his section on reboxetine. I had previously reacted to Dr. Goldacre’s comments about this drug from an article that he published in The Guardian promoting his book. For some reason, he thinks it is unfair to criticize his article. Thus, I will read the full account of reboxetine in his book and then comment.

Second, I should point out that I have just published “Devalued & Distrusted – Can the pharmaceutical industry restore its broken image?” This book was completed last June. In two separate sections of “Devalued & Distrusted” I discuss the importance of the pharma industry doing a better job of publishing clinical trial results and I cite BMJ data showing where the industry has come up short. But, I also cite another BMJ article that shows that NIH (academic-based research) HAS ALSO fallen short of meeting these same reporting goals with less than half of the NIH studies reporting results within 30 months. I include this point, not to justify pharma’s behavior, but rather to show that – unless you believe that the NIH is nefariously hiding bad results – the reporting requirement is not trivial to achieve. Yes, the industry needs to be do better but, when you include all the facts, suddenly things can look a bit different. Nevertheless, Dr. Goldacre’s charge that I have been forced to change my views is untrue as “Devalued & Distrusted” shows.

I don’t believe that pharma has fixed everything. But pharma gets no credit for trying to improve. The transparency that Pfizer has made in publishing payments to healthcare professionals is amazingly thorough. Pfizer has been doing this since 2010. This is a great model for the rest of the industry and I think will soon be standard practice – with or without legislation. Similarly, GSK has taken the unprecedented step of opening up ALL its clinical trial data for review by scientists. I believe that this action will also be emulated by others. Yet, this get ignored by industry critics.

J&J recently had a drug approved by the FDA for multidrug resistant TB. This will make no money for J&J, but they did this because it will help thousands of people around the world. In fact, if one checks the statistics of corporate philanthropy, the big pharma companies dominate the list of top donors. EVERY major pharma company has programs designed to treat diseases of the developing world, programs that are providing medicines that will generate no profits to the inventor company. Critics will trivialize this by saying that pharma does this to salve their consciences. Yes, the medicines that they discover & develop for cancer, diabetes, heart disease, arthritis, etc., etc., do generate significant profits. But these medicines save lives and improve the quality of life for hundreds of millions of people. Surely, such an industry can’t be a vile as Dr. Goldacre makes it out to be.

John LaMattina: “I’d like to point out that Dr. Goldacre has criticized me for not reading his book… I had previously reacted to Dr. Goldacre’s comments about this drug from an article that he published in The Guardian promoting his book. For some reason, he thinks it is unfair to criticize his article.”

I wouldn’t dream of expecting John LaMattina to read my book, and he is welcome to criticise any article I write. My concern was that LaMattina wrote a long (two page) article about the book, which he has now admitted he has never read. It was published here:

Since being caught out for making unfounded assertions about a book which he has never read – in a comment piece that contained many inaccuracies – Mr LaMattina has now silently changed his Forbes piece. He has replaced it with an article written to make it seem that he was always, in fact, writing about an article in the Guardian (a brief extract from the book).

Mr LaMattina no doubt thinks this is acceptable. I think many bloggers, editors, and most importantly readers would regard it as misleading, dishonest and unprofessonal to silently change the contents of a comment piece in response to critical comments. There is no great dishonour in making an error, it would be stylish to correct them openly.

Now, after silently modifying an article he has written, Mr LaMattina cites his silently modified piece to claim that my original criticisms of his work were invalid. I think this is kind of bizarre.

But in any case, I think we should move on. My main concern was that LaMattina insisted I have made assertions about shortcomings in medicine that cannot be justified (without reading the evidence I present in the book). He may well disagree with my concerns, but in reality it’s neither controversial nor incorrect to point out that there are common methodological shortcomings in trial design, that regulators make questionable decisions, that marketing can result in biased dissemination of evidence to practitioners, and that trial results are commonly withheld.

When these problems are denied – by LaMattina and others – then they are perpetuated, which perpetuates the resulting harm done to patients. Since LaMattina has set himself up as the ethical and self-crifical face of the industry, it would be good if to see him engage on these concerns without resorting to fabrication or silliness.

Regarding academics failing to publish trials, as well as industry: I have been writing about this for many years, in the Guardian, online, in Bad Pharma, and in broadcast work. It’s a scandal, and it goes beyond even medicine, you may find these articles on publication bias in the psychology literature interesting:

Not to mention this on citation bias, another fascinating form of dissemination bias in academic literature:

http://www.badscience.net/2009/08/how-myths-are-made/

Mr LaMattina has still not clarified why he advises people to break the law, and continue to withhold trial results up to 30 months. The FDA Amendment Act 2007 requires that results are posted within one year. However, as I said, the evidence shows that this law is ignored by industry more often than it is obeyed:

http://www.bmj.com/content/344/bmj.d7373

Mr LaMattina’s claims that he cites this work in his book. If this is true, then this presents a new puzzle about his approach to discussions on problems in pharma. In his previous piece about my book (which he has now silently modified) LaMattina writes:

“It is interesting to note that the information that Goldacre uses to support his view is largely pre-2007. Things are different now… with the broad use of clinicaltrials.gov. Now, every clinical trial MUST be listed on this public website and, furthermore, all the results must be listed when the trial is completed. Thus, his view that data are withheld from everyone in medicine is no longer true.”

My book demonstrates that this claim from LaMattina is untrue. The BMJ paper from 2012 – which LaMattina claims he cites in his book – also demonstrates that LaMattina’s claim is untrue. Why would John LaMattina dismiss concerns about trial results being withheld, and claim that the 2007 law and clinicaltrials.gov had fixed the problem, if he knew that this was untrue?

Ah yes, the sharp tongue and selective conscience of the Dr. Goldacre.

Dr Goldacre’s recent Guardian article informs the public “your doctor does not know if the drug s/he is prescribing works or not, because of the withholding of clinical trial data by Big Pharma. In support of this he cites a meta analysis that found when unpublished studies were included, reboxetine did not separate from placebo.

What Dr. Goldacre fails to mention is that the meta analysis he cites was criticized by both MHRA and by EMA for inappropriately excluding a large trial which showed a robust treatment effect, and that if this trial had been included, the meta analysis would have shown a statistically significant effect.

In a later conversation with Matt Herper on Twitter, Goldacre admits that inclusion of this study would have likely changed the results. Apparently ignoring clinical trials whose results are contrary to one’s position is unacceptable when selling drugs, but a perfectly fine tactic for selling books.

Why would Dr. Goldacre dismiss concerns about writing an article for the popular press that is built around a meta analysis that he knew was flawed?

While I agree that pharma’s reputation is in a sad shape, I respectfully take exception to your characterization that I minimize its achievements. The blog that you reference recognizes last year’s record number of FDA approvals as a “terrific success”, with half of these approvals going to drugs that “target novel modes of action”.

This success, however, should not obscure the fact that the industry must continue to address issues that threaten its ability to innovate. One of them is the cost of R&D, an area about which it has been remarkably opaque. Some pharma CEOs have courageously admitted that the return on drug R&D is negative. This is a serious problem, and one the industry has not been keen to fess up to (with exceptions). In a recent filing with the French government Sanofi puts its own cost of bringing a drug to market at $7.9 billion vs. an industry average of $5.8 billion. Compare this with PhRMA’s dogged insistence that this figure is only $1.2 billion, and you have perhaps another reason why the industry’s image is so tarnished. When the leaders take their distance from the facts, should we be surprised if some employees feel that it is OK to cut their own corners with ethics?

John Lechleiter, PhRMA’s Chairman, likes to portray Lilly as an innovation-driven company. Yet it has produced little of it since 2005 despite a cumulative R&D spending of over $30 billion. What does this say about his company’s cost per NME? $1.2 billion? Who is “straining credibility” as you put it?

Thirty years ago, when you and I were early in our careers, the industry was commonly known as “the ethical pharmaceutical industry”. Today such characterization brings smiles, or smirks. The industry chief executives, past and present, must accept responsibility for this decline, and, to their credit, some have. The sooner they admit and reverse the blunders of the past, and return to a true innovation culture, the greater the hope the industry can put behind the issues that have overshadowed its important contribution to society.

Bernard, Perhaps I am over-sensitized to critiques of pharma, so I apologize. I took your post to be a somewhat negative response to some great news about another year of improved productivity by the industry. It would have been nice to celebrate that achievement for a brief period. – John

No apology needed. I share your excitement about the improvement in NME approvals, and agree that there is much to celebrate in the 2012 figures (and I invite you to do a bit of celebration next time we meet). I also very much agree with your prescription to restore trust in the industry. I would add one more thing, however: companies must refrain from lionizing chief executives whose performance has been dismal. Employees and shareholders know better. Billing as a superhero someone who has squandered most of his shareholders’ value and/or underperformed the market and the industry is a form of deception. Sadly, it has happened too frequently. Untruths and misrepresentations at the top foster like behavior down below.